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This randomized controlled clinical trial will evaluate and compare the efficacy and safety of intradermal injection of exosomes, platelet-rich plasma, and corticosteroid in patients with post-herpetic neuralgia. Forty-five adult patients with dermatomal pain persisting for at least 90 days after herpes zoster will be enrolled from outpatient clinics. Participants will be assigned to one of three groups: intradermal exosome injection, intradermal autologous platelet-rich plasma injection, or intradermal triamcinolone acetonide injection. Each group will receive four treatment sessions every two weeks. Outcomes will include pain severity, neuropathic pain characteristics, quality of life, patient satisfaction, and adverse effects, assessed at baseline, at the final session, and during follow-up visits at 3 and 6 months after the last session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exosomes | Experimental | Participants will receive intradermal injections of exosome product into the affected dermatome. The dermatome will be marked and divided into 1 cm² squares, and 0.1 cc will be injected intradermally into each square using an insulin syringe. Treatment will be given every two weeks for a total of four sessions, followed by visits at 3 and 6 months after the last session. |
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| PRP | Experimental | Participants will receive intradermal injections of autologous platelet-rich plasma into the affected dermatome. Ten mL of blood will be collected under aseptic conditions and centrifuged at 1000 rpm for 10 minutes. The lower 1-2 cc of plasma will be used as platelet-rich plasma concentrate. The affected dermatome will be marked into 1 cm² squares, and 0.1 cc PRP will be injected intradermally into each square. Treatment will be given every two weeks for four sessions, followed by visits at 3 and 6 months after the last session. |
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| Corticosteroids | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exosomes | Biological | Intradermal injection of 0.1 cc exosome product per 1 cm² square into the affected dermatome, every two weeks for four sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Severity Using the Visual Analog Scale | Baseline and final treatment session, approximately 6 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neuropathic Pain Scale Score | Baseline, final treatment session, 3 months after last session, and 6 months after last session |
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Inclusion Criteria:
Male or female patients. Age 18 years or older. Willingness to comply with study procedures and attend follow-up visits. Ability and willingness to provide written informed consent
Exclusion Criteria:
Regular use of anticoagulant or antiplatelet drugs.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mona Elradi | Contact | +201067070550 | monaelradi@medicine.zu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University Hospitals | Recruiting | Zagazig | Zagazig | 44519 | Egypt |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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Participants will be assigned to one of three parallel groups: intradermal exosome injection, intradermal autologous platelet-rich plasma injection, or intradermal triamcinolone acetonide injection.
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Open-label study; participants and investigators are not masked to treatment assignment.
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| PRP | Biological | Autologous platelet-rich plasma prepared from 10 mL patient blood by centrifugation at 1000 rpm for 10 minutes, injected intradermally at 0.1 cc per 1 cm² square every two weeks for four sessions. |
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| Corticosteroids | Drug | Intradermal triamcinolone acetonide 10 mg/mL, 0.1 mL per 1 cm² square of the affected dermatome, every two weeks for four sessions |
|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |